To compare the blood levels of liposomal Doxorubicin (Sun Pharma) with Doxil® (PegylatedLiposomal doxorubicin)) in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer)

Active, not recruiting

• Conditions: Malignant neoplasm of unspecifiedovary,

• Registration Number: CTRI/2022/01/039082
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

A multicenter, open label, randomized, balanced, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin hydrochloride liposome injection 2mg/mL (50 mg/m2 dose) of Sun Pharmaceutical Industries Ltd., India with that of DOXIL® (Doxorubicin hydrochloride liposome injection) 2mg/mL (50 mg/m2 dose) of Janssen Pharmaceutical, Tokyo, Japan in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) under fed (standardized light meal) condition.

Primary objective of the study is to assess the bioequivalence between Test product (Doxorubicin hydrochloride liposome injection 2mg/mL) and Reference product DOXIL® (Doxorubicin hydrochloride liposome injection 2mg/mL) in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) under fed (standardized light meal) condition

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• Patient willing and able to provide voluntary informed consent prior to commencement of any study-related activities and the ability to follow the protocol requirements 2.
• Female patients between 18 and 75 years of age, both inclusive and having body mass index greater or equal to 17.00 calculated as weight in kg/height in m2.
• Patients with histologically confirmed mullerian carcinoma (i.e., epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) which is platinum-resistant, recurrence or in relapse state.
• Patient is able and clinically indicated to receive the recommended minimum of 2 cycles of liposomal doxorubicin HCl. 5.
• Patients having Eastern Cooperative Oncology Group performance status of lesser or equal to 2 at the time of screening 6.
• Life expectancy greater than 6 months based on the clinical evaluation by the investigator at the time of screening.
• Patients with acceptable hematology status a) Hemoglobin greater or equal to 9.0 g/dL b) Absolute neutrophil count (ANC) greater or equal to 1500 cells/μL c) Platelet count greater or equal to 75,000 cells/μL d) White blood cell counts (/ mm 3): 3,000 or more and less than 10,000 8.
• Acceptable liver function: a) Alanine aminotransferase (ALT) lesser or equal to 2.5 X ULN b) Aspartate aminotransferase (AST) lesser or equal to 2.5 X ULN c) Total Bilirubin less than 1.2 mg/dL d) Alkaline phosphatase lesser or equal to 3.0 X ULN (lesser or equal to 5 × ULN for bone metastasis) 9.
• Patients with creatinine clearance greater or equal to 60 mL perminute 10.
• Patients with left ventricular ejection fraction greater or equal to 50 percent by an echocardiogram during screening.
• Patients with a negative serum pregnancy test at screening and negative urine pregnancy test on Day 0 (only for females with child bearing potential) 12.
• Women of childbearing potential, (defined as women physiologically capable of becoming pregnant, unless, they must agree to use an effective method of contraception during dosing and up to six months after the last dose of study drug of the investigational product) practicing acceptable method of contraception.
• Acceptable methods of contraception are: a) Intrauterine device or intrauterine system b) A double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) c) Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) d) Female sterilization (surgical bilateral oophorectomy) or tubal ligation or hysterectomy for at least 6 weeks or post-menopausal for at least one-year prior to study participation e) Total abstinence, partial abstinence is not acceptable.
• Patients with no history of addiction to any recreational drug or drug dependence or alcohol addiction.

Exclusion Criteria

• Patients with known hypersensitivity or contraindication including anaphylaxis to conventional or liposomal formulations of doxorubicin, anthracycline therapy, peanut or soya or to any of their components 2.
• Patients with prior doxorubicin exposure that would result in a total lifetime exposure of more than 450 mg/m2 (prior use of other anthracyclines or anthracenodiones should be included in calculations of total cumulative dosage) 3.
• Patients who have received previous chemotherapy and radiation therapy within 4 weeks of dosing of Investigational Product 4.
• Patients with impaired cardiac function including any of the following conditions within 6 months prior to screening: a.
• Unstable angina b.
• QTc prolongation or other significant ECG abnormalities.
• Coronary artery bypass graft surgery.
• Symptomatic peripheral vascular disease.
• Myocardial infarction f.
• NYHA class II-IV heart failure g.
• Severe uncontrolled ventricular arrhythmias h.
• Clinically significant pericardial disease i.
• Electrocardiographic evidence of acute ischemic or active conduction system abnormalities 5.
• Patients who have received any prior mediastinal irradiation as cardiac toxicity may occur at even lower doses (400mg/m2) 6.
• Patients who have received trastuzumab within 24 weeks prior to dosing of investigational product and who require as part of treatment during the study 7.
• Patients taking inducers and inhibitors of CYP3A4, CYP2D6 or P-gp 8.
• Pregnant or lactating women 9.
• Patients with uncontrolled metabolic disorders including diabetes mellitus (HbA1c ≥ 9 %) at screening 10.
• Patients with active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism if under treatment with myelotoxic drugs 11.
• Patients with known central nervous system metastasis 12.
• Patients with major surgical procedure (including periodontal) within 28 days of the first dose of Investigational Product 13.
• Patients with surgical or other non-healing wounds 14.
• Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), syphilis.
• Patients with history of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer) 16.
• Patients who have not recovered to Grade 0 or 1 toxicities from previous anticancer treatments or previous investigational agents.
• Exceptions are alopecia (any grade is acceptable), Hemoglobin greater or equal to 9.0 g/dL and fatigue (Grade 2 is acceptable) {Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0}.
• Patients with any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
• Patients who have participated in any clinical study within 90 days before the first dose of Investigational Product 19.
• Patient who have donated blood and/or loss of greater or equal to 350 mL (1 unit) of blood within 90 days before the first dose of Investigational Product 20.
• Patients with pre-existing motor or sensory neurotoxicity of a severity greater or equal to grade 2 by NCI criteria.
• Patients with a history of other clinically significant concomitant diseases including gastrointestinal, pulmonary, endocrine, immunologic, dermatologic, neurologic, psychological, musculoskeletal, cardiac, liver or renal disease, bleeding tendency.
• Patient with uncontrolled hypertension (systolic blood pressure [BP] higher than 180 or diastolic BP higher than 100 mm Hg) with or without antihypertensive treatment 23.
• Patient with a history of cerebrovascular accident (CVA) within 6 months or venous thrombosis within 12 weeks (Patients with a previous history of venous thrombosis on a stable dose of anticoagulation are allowed) 24.
• Patients with confirmed novel coronavirus infection (COVID-19).

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the bioequivalence between Test product (Doxorubicin hydrochloride liposome injection 2mg/mL) and Reference product DOXIL® (Doxorubicin hydrochloride liposome injection 2mg/mL) in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer) under fed (standardized light meal) condition	Pre dose(0.0 hrs_ within 1 hrs prior to dosing. 0.250, 0.500, 0.750 hrs after start of infusion, Immediately after end of infusion, 0.083, 0.250,0.500, 1.000,3.000,5.000,8.000, 24.000, 48.000, 96.000 , 168.000, 240.000 ,336.000 hrs after end of infusion

Secondary Outcome Measures

Name	Time	Method
To monitor the adverse events and to ensure the safety of patients after investigational product administration	Not applicable

Trial Locations

Locations (17)

Aadhar Health Institute; 🇮🇳 Hisar, HARYANA, India

Erode Cancer Centre; 🇮🇳 Erode, TAMIL NADU, India

Government Rajaji Hospital; 🇮🇳 Madurai, TAMIL NADU, India

HCG Cancer Centre; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

HCG city cancer centre; 🇮🇳 Guntur, ANDHRA PRADESH, India

HCG Manavata cancer centre; 🇮🇳 Nashik, MAHARASHTRA, India

Kailash Cancer Hospital & Research centre; 🇮🇳 Vadodara, GUJARAT, India

KIMS- ICON Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

KRH Mysore Medical College & Research Institute; 🇮🇳 Mysore, KARNATAKA, India

Marathwada Regional Cancer Centre & Research Institute; 🇮🇳 Aurangabad, MAHARASHTRA, India

Scroll for more (7 remaining)

Aadhar Health Institute

🇮🇳Hisar, HARYANA, India

Dr Lovenish Goyal

Principal investigator

9896539142

Drlovenish@gmail.com